No more hypoglycaemia on days with physical activity and unrestricted diet when using a closed-loop system for 12 weeks: A post hoc secondary analysis of the multicentre, randomized controlled Diabeloop WP7 trial

Abstract

A post hoc analysis of the Diabeloop WP7 multicentre, randomized controlled trial was performed to investigate the efficacy of the Diabeloop Generation-1 (DBLG1) closed-loop system in controlling the hypoglycaemia induced by physical activity (PA) in real-life conditions. Glycaemic outcomes were compared between days with and without PA in 56 patients with type 1 diabetes (T1D) using DBLG1 for 12 weeks. After the patient announces a PA, DBLG1 reduces insulin delivery and, if necessary, calculates the amount of preventive carbohydrates (CHO). Daily time spent in the interstitial glucose range less than 70 mg/dL was not significantly different between days with and without PA (2.0% ± 1.5% vs. 2.2% ± 1.1%), regardless of the intensity or duration of the PA. Preventive CHO intake recommended by the system was significantly higher in days with PA (41.1 ± 35.5 vs. 21.8 ± 28.5 g/day; P < .0001), and insulin delivery was significantly lower (31.5 ± 10.5 vs. 34.0 ± 10.5 U/day; P < .0001). The time spent in hyperglycaemia and the glycaemic variation coefficient increased significantly on days with PA. In real-life conditions, the use of DBLG1 avoids PA-induced hypoglycaemia. Insulin adjustments and preventive CHO recommendation may explain this therapeutic benefit.

Keywords: artificial pancreas; closed-loop system; continuous glucose monitoring; glycaemic control; hypoglycaemia; insulin pump therapy; physical activity; physical intervention; randomized controlled trial; type 1 diabetes.

Conflict of interest statement

SF declares congress invitations from Sanofi, Eli Lilly, MSD, Novo Nordisk, Roche, Abbott and Boehringer; she has received speaker honoraria from Lilly and Novo Nordisk, and served on advisory board panels for Novo Nordisk, Diabeloop, Roche, Sanofi, Janssen and Lifescan. She also owns shares in Diabeloop SA. PYB has received speaker honoraria from Abbott, Roche, Eli Lilly, Novo Nordisk and Sanofi, and has served on advisory board panels for Abbott, Diabeloop, Roche, Medtronic, Dexcom, Insulet, Lifescan, Eli Lilly, Novo Nordisk and Sanofi. SB has received personal compensation for board participation and speaking fees from Abbott, Eli Lilly, Novo Nordisk, Medtronic and Sanofi Aventis. LC has received personal compensation for board participation and speaking fees from Eli Lilly, Lifescan, Novo Nordisk, Roche Diagnostics, Medtronic and Sanofi Aventis. BD has received personal compensation for board participation and speaking fees from Eli Lilly, Novo Nordisk, Sanofi Aventis, MSD and Astra Zeneca. MD is employed by Univ. Grenoble Alpes, CEA LETI, F‐38000 Grenoble. BG participated as an advisory panel/board member of Sanofi, Eli Lilly, NovoNordisk, Novartis, GSK, MSD, Boehringer Ingelheim, AstraZeneca, Abbott, Medtronic and Roche Diagnostics; he also participated as a clinical investigator for Sanofi, Eli Lilly, NovoNordisk, GSK, BMS, AstraZeneca, Medtronic, Abbott, Roche Diagnostics, MSD, Novartis, Janssen and Boehringer Ingelheim, and received research support from Medtronic, Vitalaire, Sanofi, Eli Lilly and Novo Nordisk. HH has received personal compensation for board participation and speaking fees from Abbott, Dexcom, Eli Lilly, Lifescan, Novo Nordisk, Roche Diagnostics, Medtronic, Sanofi Aventis and BD. EH is an employee of Diabeloop S.A. NJ received personal compensation for board participation and speaking fees from Eli Lilly, Novo Nordisk, Sanofi Aventis and Roche. CA has received congress invitations from Eli Lilly and AstraZeneca, and has received speaker honoraria from Diabeloop. ER is a consultant/advisor for Abbott, Air Liquide SI, Bastide Médical, Beckton‐Dickinson, Cellnovo, Dexcom, Eli‐Lilly, Hillo, Insulet, Johnson & Johnson (Animas, LifeScan), Medirio, Medtronic, Novo‐Nordisk, Roche Diagnostics and Sanofi‐Aventis, and has received research grant/material support from Abbott, Dexcom, Insulet, Roche Diagnostics and Tandem Diabetes Care. YR has received personal compensation for board participation and speaking fees from Novo Nordisk, Sanofi, Eli Lilly, Medtronic, Takeda, Abbott and Roche. PS has received speaking fees from Sanofi, Abbott and Lilly, and for participation on the boards of Novo‐Nordisk and Sanofi. C. Thivolet received personal compensation for board participation and speaking fees from Medtronic, Insulet, Sanofi, Lilly, Novo‐Nordisk and Abbott. CS, C. Thomas and PH have no conflicts of interest to declare. GC is CMO of Diabeloop SA, owns shares in Diabeloop SA, is employed by CERITD and received personal compensation for board participation, research funding and speaking fees from Astra‐Zeneca, Boehringer, Eli Lilly, Johnson & Johnson, MSD, Novo‐Nordisk, Sanofi‐Aventis and Voluntis.

© 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Figures

FIGURE 1

Time spent in hypoglycaemia during days with or without physical activity, and associated changes in carbohydrate (CHO) intake and insulin delivery. (Top) Time spent in hypoglycaemia (interstitial glucose